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Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization

 
Where Can You Report your Adverse Drug Reactions or Adverse Events Following Immunization
 

This section provides a comprehensive overview of the procedures and tools available to Healthcare Professionals, Market Authorization Holders and the General Public to report adverse events associated with medicinal products and vaccines in Lebanon.
 
How to report

You can send the case reports using the following tools:
 
  1. For Healthcare Professionals and the Public
The Lebanese National Pharmacovigilance Program has adapted two user-friendly tools: one for Adverse Drug Reactions (Vigimobile e-Reporting e-Form) and another for reporting Adverse Events Following Immunization (Vigimobile e-Form). Both tools may be accessed by healthcare professionals and the general public.
 
  1. The VigiMobile e-Form and e-Reporting e-Form:
The VigiMobile e-Form and e-Reporting e-Form are the latest tools launched in January 2025 by the Lebanese National Pharmacovigilance Program. These digital platforms were introduced to enhance the reporting process, with the e-Reporting e-Form designed for Adverse Drug Reactions (ADRs) and the VigiMobile e-Form specifically for Adverse Events Following Immunization (AEFIs).

How to Download on Android Phones
 
  1. Scan the QR Code by pressing the link
  2. Click the three dots in the top-right corner
  3. Choose Install app
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app
 
How to Download on Apple IOS Phones
 
  1. Scan the QR Code by pressing the link
  2. Click on the share button
  3. Add VigiMobile to the home screen
  4. VigiMobile e-Form/e-Reporting e-Form now appears as an app

How to Download on Windows
  1. Press on the link
  2. Install from the Browser menu
  3. VigiMobile e-Form/e-Reporting e-Form is now installed 
 
Scan QR Codes to Report:
  1. ADRs Following Medication Use
  1. AEFIs Following Vaccine Use
Or use the following link: LNPVP: e-Reporting eForm Or use the following link: LNPVP: VigiMobile eForm
 
  1. Direct Contact with the Lebanese National Pharmacovigilance Program:
You may contact the Lebanese National Pharmacovigilance Program through:
  • Email Address:
  • Phone number of the Quality Assurance of Pharmaceutical Products Program: 01-830254   
 
  1.  For Market Authorization Holders:
Based on the Ministerial Resolution MR #181 issued in 2021, MAHs should adhere to the internationally agreed ICH guidelines and standards and send the reports in XML format as specified in ICH E2B (R2 or R3) guidelines

(https://www.moph.gov.lb/userfiles/files/Quality%26Safety/PharmacovigilanceSystemInLebanon/Karar%20181-2021.pdf).

All XML files should be sent to the following emails: pv@moph.gov.lb, and pv.moph@gmail.com.
 
As for what to report or report type, you can refer to Module VI:
https://moph.gov.lb/en/Pages/4/44742/pharmacovigilance-system-lebanon#/en/view/70479/lebanese-guideline-on-good-pharmacovigilance-practices-lgvp-
 
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ATC Name B/G Ingredients Dosage Form Price
G04BD08 URICARE G Solifenacin succinate - 10mg 10mg Tablet, film coated 1,334,884 L.L
G04BD08 URISOL G Solifenacin succinate - 10mg 10mg Tablet, film coated 1,334,884 L.L
G04BD08 VESICARE B Solifenacin succinate - 5mg 5mg Tablet, film coated 1,619,330 L.L
G04BD08 ASOLFENA G Solifenacin succinate - 5mg 5mg Tablet, film coated 971,598 L.L
G04BD08 SOLIFAS G Solifenacin succinate - 5mg 5mg Tablet, film coated 971,598 L.L
G04BD08 SOLIFENACINE ARROW G Solifenacin succinate - 5mg 5mg Tablet 952,784 L.L
G04BD08 URICARE G Solifenacin succinate - 5mg 5mg Tablet, film coated 1,334,884 L.L
G04BD08 URISOL G Solifenacin succinate - 5mg 5mg Tablet, film coated 1,334,884 L.L
H01AC01 CINNATROPIN BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 9,012,607 L.L
H01AC01 NORDITROPIN NORDIFLEX BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 14,532,052 L.L
H01AC01 OMNITROPE BioTech Somatropin recombinant - 10mg/1.5ml 10mg/1.5ml Injectable solution 45,388,478 L.L
H01AC01 GENOTROPIN GOQUICK BioTech Somatropin recombinant - 12mg/ml 12mg/ml Injectable powder for solution+diluent 25,170,264 L.L
H01AC01 HHT BioTech Somatropin recombinant - 16IU (5.32mg) 16IU (5.32mg) Injectable freeze dried powder + diluent 4,078,562 L.L
H01AC01 GENOTROPIN BioTech Somatropin recombinant - 5.3mg/1.15ml 5.3mg/1.15ml Injectable powder for solution+diluent 4,724,854 L.L
H01AC01 CINNATROPIN BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 4,699,417 L.L
H01AC01 NORDITROPIN NORDIFLEX BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 7,582,922 L.L
H01AC01 OMNITROPE BioTech Somatropin recombinant - 5mg/1.5ml 5mg/1.5ml Injectable solution 26,295,375 L.L
L01EX02 NEXAVAR B Sorafenib - 200mg 200mg Tablet, film coated L.L
L01EX02 NEXAVAR B Sorafenib - 200mg 200mg Tablet, film coated 82,858,698 L.L
A03AX HEPABYL G Sorbitol - 2.5g/5ml, Diisopromine - 0.02g/5ml Liquid 238,052 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 160mg 160mg Tablet, scored 357,462 L.L
C07AA07 SOTALOL BIOGARAN G Sotalol hydrochloride - 80mg 80mg Tablet, scored 288,926 L.L
B05BA02 SMOFLIPID G Soya oil - 6%, Olive oil - 5%, Fish oil - 3%, Medium chain triglycerides - 6% 20% Injectable emulsion 1,424,473 L.L
J01FA02 ROVAMYCINE B Spiramycin - 1.5MIU 1.5MIU Tablet, film coated 256,674 L.L
J01FA02 ROVAMYCINE B Spiramycin - 3MIU 3MIU Tablet, film coated 649,076 L.L
C03DA01 ALDACTONE B Spironolactone - 100mg 100mg Tablet 458,250 L.L
C03DA01 ALDACTONE B Spironolactone - 25mg 25mg Tablet 237,860 L.L
B05AA07 VOLUVEN B Starch poly(O-2-Hydroxyethyl) - 6% 6% Injectable solution 987,724 L.L
J07CA LANTIGEN B B Streptococcus pneumoniae type 3 (antigenic extracts) - 63.2A.U./ml, Streptococcus pyogenes group A (antigenic extracts) - 126.2A.U./ml, Branhamella catarrhalis (antigenic extracts) - 39.9A.U./ml, Staphylococcus aureus (antigenic extracts) - 79.6A.U./ml, Haemophilus influenzae type b (antigenic extracts) - 50.2A.U./ml, Klebsiella pneumoniae (antigenic extracts) - 39.8A.U./ml Drops suspension 916,501 L.L
A02BX02 SUCRATE GEL G Sucralfate - 1g 1g Gel 636,981 L.L
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